Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-01 @ 3:31 PM
Study NCT ID:
NCT05444192
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018409', 'term': 'Foot Injuries'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D005413', 'term': 'Flatfoot'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gchapman2@uclan.ac.uk', 'phone': '01772894949', 'title': 'Dr Graham Chapman', 'organization': 'University of Central Lancashire'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 months', 'eventGroups': [{'id': 'EG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 7, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 2, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Advenrse event', 'notes': 'Discomfort in the arch area of the foot (n=7), the lateral midfoot (n=1) and the forefoot (n=1).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'OG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'classes': [{'title': '12 weeks following intervention', 'categories': [{'measurements': [{'value': '78.13', 'groupId': 'OG000', 'lowerLimit': '53.75', 'upperLimit': '92.97'}, {'value': '78.75', 'groupId': 'OG001', 'lowerLimit': '53.75', 'upperLimit': '93.75'}]}]}, {'title': '8 weeks following intervention', 'categories': [{'measurements': [{'value': '72.50', 'groupId': 'OG000', 'lowerLimit': '49.53', 'upperLimit': '84.38'}, {'value': '78.13', 'groupId': 'OG001', 'lowerLimit': '54.06', 'upperLimit': '85.00'}]}]}, {'title': '4 weeks following intervention', 'categories': [{'measurements': [{'value': '72.50', 'groupId': 'OG000', 'lowerLimit': '57.19', 'upperLimit': '84.38'}, {'value': '78.13', 'groupId': 'OG001', 'lowerLimit': '48.13', 'upperLimit': '84.38'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.13', 'groupId': 'OG000', 'lowerLimit': '29.38', 'upperLimit': '71.88'}, {'value': '53.75', 'groupId': 'OG001', 'lowerLimit': '27.19', 'upperLimit': '72.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention', 'description': 'To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Foot Health Status Questionnaire (FHSQ) - Function Sub-domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'OG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'classes': [{'title': '12 weeks following intervention', 'categories': [{'measurements': [{'value': '87.50', 'groupId': 'OG000', 'lowerLimit': '68.75', 'upperLimit': '100.00'}, {'value': '93.75', 'groupId': 'OG001', 'lowerLimit': '65.63', 'upperLimit': '100.0'}]}]}, {'title': '8 weeks following intervention', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '51.56', 'upperLimit': '93.75'}, {'value': '93.75', 'groupId': 'OG001', 'lowerLimit': '59.38', 'upperLimit': '100.00'}]}]}, {'title': '4 weeks following intervention', 'categories': [{'measurements': [{'value': '87.50', 'groupId': 'OG000', 'lowerLimit': '57.81', 'upperLimit': '93.75'}, {'value': '87.50', 'groupId': 'OG001', 'lowerLimit': '62.50', 'upperLimit': '100.00'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '68.75', 'groupId': 'OG000', 'lowerLimit': '43.75', 'upperLimit': '87.50'}, {'value': '62.50', 'groupId': 'OG001', 'lowerLimit': '37.50', 'upperLimit': '90.63'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention', 'description': 'To compare the changes in foot function in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Foot Health Status Questionnaire - Foot Health Sub-domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'OG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'classes': [{'title': '12 weeks following intervention', 'categories': [{'measurements': [{'value': '60.00', 'groupId': 'OG000', 'lowerLimit': '25.00', 'upperLimit': '81.88'}, {'value': '72.50', 'groupId': 'OG001', 'lowerLimit': '25.00', 'upperLimit': '85.00'}]}]}, {'title': '8 weeks following intervention', 'categories': [{'measurements': [{'value': '46.25', 'groupId': 'OG000', 'lowerLimit': '25.00', 'upperLimit': '69.38'}, {'value': '72.50', 'groupId': 'OG001', 'lowerLimit': '25.00', 'upperLimit': '85.00'}]}]}, {'title': '4 weeks following intervention', 'categories': [{'measurements': [{'value': '42.50', 'groupId': 'OG000', 'lowerLimit': '25.00', 'upperLimit': '72.50'}, {'value': '60.00', 'groupId': 'OG001', 'lowerLimit': '25.00', 'upperLimit': '85.00'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '60.00'}, {'value': '42.50', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '72.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention', 'description': 'To compare the changes in foot health in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'OG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '69.48', 'groupId': 'OG000', 'lowerLimit': '64.59', 'upperLimit': '74.36'}, {'value': '76.35', 'groupId': 'OG001', 'lowerLimit': '71.84', 'upperLimit': '80.86'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured 12 weeks after being fitted with insoles', 'description': 'To compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differential Cost Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'OG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '55.46', 'groupId': 'OG000', 'lowerLimit': '51.28', 'upperLimit': '60.36'}, {'value': '44.94', 'groupId': 'OG001', 'lowerLimit': '39.98', 'upperLimit': '48.12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Costs were calculated per participant from baseline until their completion of the trial at week 12.', 'description': 'A differential cost analysis was undertaken. This involved calculating the total cost for each participant using a calculation of transit costs, staff time, and physical resources for each participant throughout their time in the trial.', 'unitOfMeasure': 'cost in pounds and pence per participant', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Outcome Measure - Hours of Insole Wear Time Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'OG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '5.08', 'groupId': 'OG000', 'lowerLimit': '4.66', 'upperLimit': '5.50'}, {'value': '6.09', 'groupId': 'OG001', 'lowerLimit': '5.68', 'upperLimit': '6.51'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured from baseline until completion of the trial at week 12', 'description': 'Patients will keep a diary of daily wear time in hours, in accordance with prior publications on measuring Orthotic Adherence. The minimum threshold for adherence is \\>21 hours per week', 'unitOfMeasure': 'Hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tertiary Outcome Measure - Dropout Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'OG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured from baseline to completion of the trial at 12 weeks, for each participant', 'description': 'Dropout rate = n dropout at end of trial', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'FG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Assessed for eligibility (n=118) Excluded (n=4)\n\n* Already has suitable insoles (n=2)\n* Not suitable for treatment with insoles (n=1)\n* Declined to participate (n=1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insoles Manufactured From Foam-box Cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'BG001', 'title': 'Insoles Manufactured From Direct 3D Scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.\n\nCAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'BG000', 'lowerLimit': '32.0', 'upperLimit': '61.0'}, {'value': '50.0', 'groupId': 'BG001', 'lowerLimit': '34.0', 'upperLimit': '59.0'}, {'value': '50.0', 'groupId': 'BG002', 'lowerLimit': '33.0', 'upperLimit': '60.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Other (mixed)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'African', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Area of primary musculoskeletal pathology', 'classes': [{'categories': [{'title': 'Ankle', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'First ray', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Forefoot', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Lower leg', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Midfoot', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Plantar heel / plantar fascia', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "A review of all relevant medical history from the participant's medical record was undertaken to determine primary pathology, in conjunction with a physical examination of the foot and ankle, including the following standard biomechanical tests\n\n1. Foot Posture Index\n2. Jacks test for Functional Hallux Limitus\n3. Palpation technique for Subtalar Joint Axis Location\n4. Passive assessment of ankle dorsiflexion stiffness by 'position of first detectable resistance\n5. Supination resistance test\n6. Visual gait analysis", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-08', 'size': 928511, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-07T05:44', 'hasProtocol': True}, {'date': '2022-09-08', 'size': 489032, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-07T09:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2022-06-16', 'resultsFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-07', 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tertiary Outcome Measure - Hours of Insole Wear Time Per Day', 'timeFrame': 'Measured from baseline until completion of the trial at week 12', 'description': 'Patients will keep a diary of daily wear time in hours, in accordance with prior publications on measuring Orthotic Adherence. The minimum threshold for adherence is \\>21 hours per week'}, {'measure': 'Tertiary Outcome Measure - Dropout Rate', 'timeFrame': 'Measured from baseline to completion of the trial at 12 weeks, for each participant', 'description': 'Dropout rate = n dropout at end of trial'}], 'primaryOutcomes': [{'measure': 'Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain', 'timeFrame': 'Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention', 'description': 'To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Foot Health Status Questionnaire (FHSQ) - Function Sub-domain', 'timeFrame': 'Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention', 'description': 'To compare the changes in foot function in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.'}, {'measure': 'Foot Health Status Questionnaire - Foot Health Sub-domain', 'timeFrame': 'Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention', 'description': 'To compare the changes in foot health in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.'}, {'measure': 'Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey)', 'timeFrame': 'Measured 12 weeks after being fitted with insoles', 'description': 'To compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.'}, {'measure': 'Differential Cost Analysis', 'timeFrame': 'Costs were calculated per participant from baseline until their completion of the trial at week 12.', 'description': 'A differential cost analysis was undertaken. This involved calculating the total cost for each participant using a calculation of transit costs, staff time, and physical resources for each participant throughout their time in the trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Foot Injury', 'Foot Deformity', 'Foot Sprain', 'Feet, Flat', 'Foot Ankle Injuries']}, 'referencesModule': {'references': [{'pmid': '40121418', 'type': 'DERIVED', 'citation': 'Barr L, Richards J, Dickson C, Tawse J, Munro N, Scott H, Holland A, Chapman GJ. To scan or not to scan? Comparing the effectiveness and cost differential of insoles manufactured from foam-box casts versus direct scans in treating musculoskeletal conditions of the foot and ankle: a double-blinded, randomised controlled trial. BMC Musculoskelet Disord. 2025 Mar 22;26(1):282. doi: 10.1186/s12891-025-08513-2.'}, {'pmid': '38569685', 'type': 'DERIVED', 'citation': 'Barr L, Richards J, Chapman GJ. Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial. BMJ Open. 2024 Apr 2;14(4):e078240. doi: 10.1136/bmjopen-2023-078240.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to find out if scanning the foot using a 3D scanner influences the effectiveness of custom made insoles, compared to the more traditional approach of taking a foam-box impression cast of the foot. Both of these methods are currently used as standard care in the NHS Greater Glasgow and Clyde (GGC) Orthotic Department. In this study, insoles will be manufactured either from a direct 3D scan of the foot, or from a foam-box impression cast, and a series of questionnaires will be used to measure any changes in foot pain and foot function. The results from this study will be used to develop an information resource for both patients and Orthotists which will fill gaps in our current knowledge and hopefully guide us further in providing the best possible care for future patients who require insoles.', 'detailedDescription': 'A single centre, double blinded, randomised controlled trial. Interventional, equivalence Trial design.\n\nParticipants will be asked to attend 2 face-to-face appointments for assessing and fitting of insoles, which is standard practice in the NHS GGC Orthotic Department. Each face-to-face appointment will take approximately 40 minutes. Following the fitting of the insoles, participants will be asked to participate in 3 telephone calls over 12-weeks, during which they will be asked to answer questions from two questionnaires (the "Foot Health Status Questionnaire", and the "Orthotic and Prosthetic User Survey"). Each telephone appointment will take approximately 15 minutes. Once participants receive their insoles, they will also be asked to keep a diary detailing the number of hours that they wore the insoles each day over 12-weeks. This information will be collected by the Orthotist involved with the trial during the telephone review appointments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are aged 18 years or above\n* Are referred to the NHS GGC Orthotic service requiring a new assessment for insoles\n* are deemed suitable for CAD/CAM insoles as assessed by the PI or Co-I on clinical assessment\n* Are able to commit to five appointments over a 16-week period (two Face-to-Face appointments, three Telephone Appointments)\n* Have suitable own footwear that can accommodate a CAD/CAM insole as assessed by the PI or Co-I, and as per standard practice can wear these for 12-weeks\n* Is willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial.\n* An adequate understanding of written and verbal information in English in order to provide informed consent and answer the study questionnaires\n\nExclusion Criteria:\n\n* Scheduled elective surgery or other procedures which is likely to affect mobility during the trial.\n* Scheduled steroid injection of the foot or ankle up to 3 months prior to joining the trial, or during participation in the trial\n* Age \\<18 years\n* Adult with Incapacity, under The Adults with Incapacity (Scotland) Act 2000\n* Participant unable or unwilling to consent\n* Medial longitudinal Arch height of the foot exceeds depth of EVA blank (35mm)\n* Clinical assessment concludes that the participant requires an insole material other than EVA\n* Clinical assessment concludes that the participant does not require or will be unlikely to benefit from CAD/CAM insoles.\n* The participant is unable to commit to the trial conditions.\n* Peripheral Neuropathy present\n* Active foot ulceration present\n* Participant with life expectancy of less than 6 months.\n* Any other significant disease or disorder which, in the opinion of the PI or Co-I, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n* Participants who have participated in another research trial involving an investigational foot orthosis in the past 12 weeks."}, 'identificationModule': {'nctId': 'NCT05444192', 'briefTitle': 'Comparing Clinical Outcomes Using Two Insole Manufacture Techniques', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Comparing the Effectiveness of Computer-aided-design Computer-aided-manufacture (CAD/CAM) Insoles Manufactured From Foam-box Cast vs Direct Scan on Patient Reported Outcome Measures: A Double-blinded, Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'GN22OR165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'insoles manufactured from foam-box cast', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.', 'interventionNames': ['Device: CAD/CAM insoles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insoles manufactured from direct 3D scan', 'description': 'Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.', 'interventionNames': ['Device: CAD/CAM insoles']}], 'interventions': [{'name': 'CAD/CAM insoles', 'type': 'DEVICE', 'description': 'computer-aided-design computer-aided-manufacture (CAD/CAM) insoles', 'armGroupLabels': ['insoles manufactured from direct 3D scan', 'insoles manufactured from foam-box cast']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G4 0SF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Orthotics Department, Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Graham Chapman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Central Lancashire'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data is available after publication', 'ipdSharing': 'YES', 'description': 'Anonymised data available on request via email to the corresponding author', 'accessCriteria': 'For academic and research purposes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Central Lancashire', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}